Cybersecurity for the Chemical & Pharmaceutical Sector

Chemical, pharmaceutical and biotech industry. 50-5000 employees.

Applicable Regulations

ACN Determination - NIS2 Security Measures

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Determina ACN 38565/2025

Soggetti essenziali e importanti registrati presso ACN. Authority: ACN - Agenzia per la Cybersicurezza Nazionale.

Penalties: Sanzioni previste dal D.Lgs. 138/2024

Authority: ACN - Agenzia per la Cybersicurezza Nazionale

Deadline: April 14, 2025

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AI Act

4 guides

EU Regulation 2024/1689

Regulation of artificial intelligence systems in the EU with a risk-based approach. Phased application: prohibited practices from Feb 2, 2025, GPAI obligations from Aug 2, 2025, high-risk systems from Aug 2, 2026

Penalties: Up to €35M or 7% of turnover (prohibited practices); €15M or 3% (other obligations); €7.5M or 1% (inaccurate information). SMEs: proportionate caps

Authority: AI Office (EU Commission) + AgID (Italy)

Deadline: August 2, 2026

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GDPR

4 guides

EU Regulation 2016/679

Personal data protection in the European Union

Penalties: Up to €20M or 4% of annual global turnover

Authority: Data Protection Authority (Garante per la Protezione dei Dati Personali)

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ISO 27001

2 guides

ISO/IEC 27001:2022 - International standard

Information Security Management System (ISMS)

Penalties: N/A (voluntary standard)

Authority: Accredited certification bodies (Accredia in Italy)

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Legislative Decree 138/2024 - NIS2 Transposition

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D.Lgs. 138/2024

Soggetti essenziali e importanti nei 18 settori NIS2 (50+ dipendenti o 10M+ fatturato). Authority: ACN - Agenzia per la Cybersicurezza Nazionale.

Penalties: Fino a 10 milioni di euro o 2% del fatturato mondiale annuo

Authority: ACN - Agenzia per la Cybersicurezza Nazionale

Deadline: October 16, 2024

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NIS2

4 guides

EU Directive 2022/2555 - Legislative Decree 138/2024

Network and information security for essential and important entities

Penalties: Up to €10M or 2% of annual turnover

Authority: ACN - National Cybersecurity Agency

Deadline: October 17, 2024

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